Women With Previous GDM and the Effects of HIIT.

NCT07566845 | Enrolling By Invitation DMC

• 1 other identifier: 25/55674
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate if women with previous gestational diabetes (pGDM) are characterized with unique metabolic and molecular alterations compared to women without pGDM. Furthermore if 8 weeks of high-intensity interval training (HIIT) can improve these alterations. The main questions we aim to answer are:

1. 1.Women with pGDM have metabolic abnormalities compared with women without pGDM, and that these metabolic abnormalities are explained by unique molecular abnormalities in skeletal muscle and adipose tissue.
2. 2.Eight weeks of HIIT combining rowing and cycling can markedly improve these metabolic abnormalities in women with pGDM and these improvements are explained by beneficial cellular and molecular changes in skeletal muscle and adipose tissue.

Conditions

Gestational Diabetes Mellitus (GDM); Type 2 Diabetes (T2DM); High-intensity Interval Training

Keywords

GDM; HIIT; T2DM

Outcome Measures

Primary Outcomes (7)

• β-cell function by OGTT

  Will be estimated as the disposition index (DI) by oral glucose tolerance test (OGTT) derived indices of insulin sensitivity and insulin secretion, after a 2-hour OGTT (75g) with measurement of plasma glucose, serum insulin and serum C-peptide at 0, 30 and 120 min.

  At screening visit.

• β-cell function by Botnia-clamp

  β-cell function adjusted for insulin sensitivity will be determined by calculating the DI as a product of the acute insulin response to glucose (AIRg) and insulin-stimulated glucose infusion rate (GIR).

  At examination day 2 and 4.

• Whole body composition (lean body mass and fat mass)

  Will be obtained by a dual-energy X-ray absorptiometry (DXA) scanning (Prodigy Advance, GE Healthcare, CHI, US)

  At examination day 1 and 3.

• Lean body mass

  Will be obtained by a dual-energy X-ray absorptiometry (DXA) scanning (Prodigy Advance, GE Healthcare, CHI, US)

  At examination day 1 and 3.

• Fat mass

  Will be obtained by a dual-energy X-ray absorptiometry (DXA) scanning (Prodigy Advance, GE Healthcare, CHI, US)

  At examination day 1 and 3.

• Cardiorespiratory fitness (maximal oxygen consumptions (VO2-max))

  Will be determined by an incremental exercise test on a cycle ergometer (SRM Ergometer System, Jülich, DE) combined with mixed chamber cardiopulmonary exercise analyzer (Oxigraf, Model O2CPX, California, US)

  At examination day 1 and 3.

• Insulin sensitivity by Botnia-clamp

  Consisting of a hyperinsulinemic-euglycemic clamp (insulin 40mU/min/m2 for 3 h) combined with a 60 min intravenous glucose tolerance test (IVGGT) using a glucose bolus (0.3 kg per kg body weight with a maximum of 25 g glucose).

  At examination day 2 and 4.

Secondary Outcomes (11)

• Plasma-specific metabolomics by LC- and GC-MS

  At examination day 2 and 4.

• Tissue-specific metabolomics by LC- and GC-MS

  At examination day 2 and 4.

• Proteomics

  At examination day 2 and 4.

• Phosphoproteomics

  At examination day 2 and 4.

• Transcriptional profiling and gene expression

  At examination day 2 and 4.

Other Outcomes (6)

• Lipid profile

  At examination day 2 and 4.

• HbA1c

  At examination day 2 and 4.

• Insulin

  At examination day 2 and 4.

Study Arms (2)

Women with previous gestational diabetes mellitus

EXPERIMENTAL

Women with previous gestational diabetes mellitus, aged 25-45, who gave birth 2-8 years ago.

Other: High-intensity interval training

Women without previous gestational diabetes

ACTIVE COMPARATOR

Women without previous gestational diabetes mellitus, aged 25-45, who gave birth 2-8 years ago.

Other: High-intensity interval training

Interventions

High-intensity interval training OTHER

The training intervention consists of 8-weeks of HIIT combining rowing and cycling on ergometers with two supervised sessions weekly in small groups of up to 10 participants. All HIIT sessions will start with a 10-min warm-up period followed by training blocks of 5 x 1 min high-intensity intervals (100-110% of Wattmax corresponding to ≥ 85% of maximum heart rate (HRmax)) each interspersed by 1 min active or resting recovery. Between the training blocks, the participants will have a 4-min break in which they shift from cycling to rowing or vice versa. The number of training blocks will gradually increase from two to five blocks during the 8-week intervention period with one block being added every second week. Halfway through the HIIT-protocol the workload will be adjusted according to a midway VO2max test. Participants will wear a heart monitor during training sessions.

Women with previous gestational diabetes mellitus; Women without previous gestational diabetes

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 25-45 years
• BMI 20-35 kg/m2
• years since the last pregnancy
• No known diabetes or PCOS
• No previous bariatric surgery
• No known disease
• Be drug-naive
• Have a regular menstrual cycle (23-35 days)
• Not be pregnant or planning pregnancy during the study period
• Low or moderate level of physical activity must be (max 2 hours of moderate exercise weekly).
• All participants should be able to provide informed consent
• Women without pGDM must not have known hypertension or first-degree relatives with diabetes.

You may not qualify if:

• Abnormal cardiac stethoscopy, ECG or screening blood tests
• Positive plasma GAD-65 antibodies
• Positive plasma choriogonadotropine
• Undiagnosed T2D based on fasting plasma glucose (≥ 7.0 mmol/mol), plasma HbA1c (≥ 48 mmol/mol), or 2-h plasma glucose during an oral glucose tolerance test (OGTT) (≥ 11.1 mmol/mol)
• Dyslipidemia (plasma LDL-cholesterol \> 5.0 mmol/l)
• In women with pGDM: Undiagnosed severe hypertension (blood pressure \> 160/100)
• In women without pGDM: Undiagnosed hypertension (blood pressure \>140/90 mmHg) or impaired glucose tolerance (fasting plasma glucose at 6.16.9 mmol/l, plasma HbA1c at 42-47 mmol/mol, or a 2-h glucose at 7.8-11.0 mmol/l during an OGTT).

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Steno Diabetes Center Odense, Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 2

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kurt Højlund, Prof. Dr. med.

  Steno Diabetes Center Odense, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Both groups will undergo same examinations and training-intervention.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: May 5, 2026
• Study Start: March 13, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)